Trial Outcomes & Findings for Evaluation of a Radial Arterial Line's Effect on StO2 Monitoring (NCT NCT00298090)

Results Overview

Using near-infrared spectroscopy, the external device recorded raw StO2 values every 3.5 seconds for approximately 5 minutes prior to and immediately following the insertion of a radial arterial catheter on the ipsilateral side. The raw values were then compiled into one-minute averages.

Recruitment status

COMPLETED

Target enrollment

47 participants

Primary outcome timeframe

up to 15 minutes

Results posted on

2014-11-26

Participant Flow

Subjects were recruited from inpatients at a local hospital's Intensive Care Unit (ICU)

Participant milestones

Participant milestones
Measure	StO2 Values Pre and Post Arterial Line Placement single arm study of StO2 in subjects undergoing placement of arterial line. Measurements of StO2 will be taken before and after arterial line placement.
Overall Study STARTED	47
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of a Radial Arterial Line's Effect on StO2 Monitoring

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	StO2 Values n=47 Participants StO2 values pre and post arterial line placement.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	19 Participants n=93 Participants
Sex: Female, Male Male	28 Participants n=93 Participants
Region of Enrollment United States	47 participants n=93 Participants

PRIMARY outcome

Timeframe: up to 15 minutes

Population: Data from 18 subjects not used due to only partial data captured resulting from logistical issues.

Using near-infrared spectroscopy, the external device recorded raw StO2 values every 3.5 seconds for approximately 5 minutes prior to and immediately following the insertion of a radial arterial catheter on the ipsilateral side. The raw values were then compiled into one-minute averages.

Outcome measures

Outcome measures
Measure	StO2 Values n=29 Participants StO2 pre and post catheter placement
Tissue Oxygen Saturation (StO2) Measurement on the Extremity With a Radial Arterial Line	0.68 StO2 percent saturation Interval -0.8 to 1.48

Adverse Events

StO2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jane Youngers

UTHSCSA

Phone: 210-567-2340

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place